For major depressive disorder (Adjunctive) in adultsAdding CAPLYTA demonstrated superior depression symptom relief in MDD patients with or without symptoms of anxiety* compared to an antidepressant alone1,2

Change from baseline in MADRS total score at 6 weeks1,2
This graph illustrates the LSM change from baseline for patients receiving CAPLYTA 42 mg or placebo.This graph illustrates the LSM change from baseline for patients receiving CAPLYTA 42 mg or placebo.

~15-point, clinically meaningful and significant improvement in depressive symptoms2

MDD patients with or without symptoms of anxiety* were included in the study2

All patients had moderate or severe depression at baseline and
CAPLYTA + ADT separated from ADT alone in 1 week2

Weekly time points prior to 6 weeks were not powered for statistical comparison and are descriptive only.

*CAPLYTA is not approved for the treatment of anxiety disorders. Symptoms of anxiety in patients with MDD are based on DSM-5 criteria for anxious distress.

Secondary endpoints:

  • 46% and 40% of CAPLYTA-treated patients achieved response at 6 weeks (defined as MADRS Total Score ≥50% reduction from baseline) in Studies 501 and 502, respectively2
  • 26% and 25% of patients achieved remission at 6 weeks (defined as MADRS total score ≤10) in Studies 501 and 502, respectively2

Limitation: These secondary endpoints were not powered for statistical comparison and are descriptive only; results require cautious interpretation.

ADT=antidepressant therapy; DSM=Diagnostic and Statistical Manual of Mental Disorders; LSM=least squares mean; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; PHQ-9=Patient Health Questionnaire-9.

Pivotal adjunctive MDD studies: Pooled study design and baseline characteristics

CAPLYTA trials in adults with major depressive disorder (MDD)1

This shows a bar labeled Mild, Moderate, and Severe with a marker placed near the Severe end of the scale.

Patients had moderate to
severe depression1
Mean baseline MADRS total scores for CAPLYTA patients: 30.4 in Study 501, and 30.8 in Study 502. Scores were similar for the placebo + antidepressant group (30.1 and 31.5, respectively).

  • 100%of patients had moderate
    to severe depressive symptoms1,2
  • ~90%of patients had inadequate response to 1 prior antidepressant therapy in the current episode2
  • 41%of patients had symptoms of anxiety* at baseline2

*CAPLYTA is not approved for the treatment of anxiety disorders. Symptoms of anxiety in patients with MDD are based on DSM-5 criteria for anxious distress.

Studies 501 (N=485) and 502 (N=480) were global, multicenter, randomized, double-blind, placebo-controlled trials1,4,5

  • Screening phaseUp to 2 weeks

    • Patients were 18-65 years old1
    • Met DSM-5 criteria and had1:
      • Inadequate response (<50% improvement to 1-2 courses of antidepressant therapy)1
      • Moderate to severe
        depressive symptoms (MADRS ≥24)4,5

  • Treatment phase6 weeks

    Oral CAPLYTA 42 mg
    (without titration) +
    an antidepressant

    Placebo + an antidepressant

  • Follow up phase1 week

    Safety Follow-Up

At 6 weeks, there was a significant symptom relief with a placebo-subtracted difference of -4.9 points in Study 501 and -4.5 points in Study 502.1 A ≥2-point difference from placebo is considered clinically meaningful.6

The primary efficacy measure was mean change in MADRS total score at 6 weeks1

Baseline antidepressant treatments

Enrolled patients were taking common antidepressants, including2:

SSRI

  • Citalopram
  • Escitalopram
  • Sertraline
  • Paroxetine
  • Fluoxetine
  • Vortioxetine
  • Vilazodone

SNRI

  • Venlafaxine
  • Desvenlafaxine
  • Duloxetine
  • Levomilnacipran
  • Milnacipran (where locally approved)

Other

  • Bupropion

Full graph description

These graphs depict the change from baseline in MADRS total score in two pivotal studies over 6 weeks, for adult patients receiving CAPLYTA 42 mg or placebo as adjunctive therapy with an antidepressant.2

In Study 501, patients on CAPLYTA saw a 14.7-point reduction at 6 weeks compared to a 9.8-point reduction with placebo (placebo-subtracted difference of -4.9; P<0.0001). In Study 502, patients on CAPLYTA saw a 14.7-point reduction at 6 weeks compared to 10.2-point reduction with placebo (placebo-subtracted difference of 4.5; P<0.0001).2

MADRS is a validated rating scale used in clinical trials to support an MDD indication by the FDA1,7-10

The MADRS total score ranges from 0 to 60. Higher scores reflect greater symptom severity. Each item is rated to assess depression severity and/or monitor response to antidepressant medication.

Symptom severity score

Each item on this 10-item scale is scored from 0 to 6, with 0 being the least severe and 6 being most severe

  1. Reported Sadness
  2. Apparent Sadness
  1. Concentration Difficulties
  2. Lassitude
  1. Inability to Feel
  2. Inner Tension (Anxiety)
  1. Reduced Sleep
  2. Reduced Appetite
  1. Pessimistic Thoughts
  2. Suicidal Thoughts

The total score ranges from 0 to 60

A horizontal scale divided into four ranges: Normal (0-6), Mild (7-19), Moderate (20-34), and Severe (35-60).

DSM=Diagnostic and Statistical Manual of Mental Disorders; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; SNRI=serotonin-norepinephrine reuptake inhibitor; SSRI=selective serotonin reuptake inhibitor.

See pooled results for MADRS individual items
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References: 1. CAPLYTA Prescribing Information. 2. Data on File (REF-02960). 3. Hawley CJ, Gale TM, Smith PSJ, et al. Equations for converting scores between depression scales (MADRS, SRS, PHQ‑9 and BDI‑II): good statistical, but weak idiographic, validity. Hum psychopharmacol. 2013;28(6):544–551. doi:10.1002/hup.2341 4. Clinical trial of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder. ClinicalTrials.gov. identifier: NCT04985942 Updated May 2, 2025. Accessed June 25, 2025. https://clinicaltrials.gov/study/NCT04985942 5. Multicenter study of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder. ClinicalTrials.gov identifier: NCT05061706 Updated May 5, 2025. Accessed July 17, 2025. https://clinicaltrials.gov/study/NCT05061706 6. Montgomery SA, Moller HJ. Is the significant superiority of escitalopram compared with other antidepressants clinically relevant? Int Clin Psychopharmacol. 2009;24(3):111‑118. doi:10.1097/YIC.0b013e32832a8eb2 7. Hengartner MP, Jakobsen JC, Sorensen A, Ploderl M. Efficacy of new‑generation antidepressants assessed with the Montgomery‑Asberg Depression Rating Scale, the gold standard clinician rating scale: A meta‑analysis of randomised placebo‑controlled trials. PLoS One. 2020;15(2):e0229381. doi:10.1371/journal.pone.0229381 8. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382‑389. doi:10.1192/bjp.134.4.382 9. Quilty LC, Robinson JJ, Rolland JP, Fruyt FD, Rouillon F, Bagby RM. The structure of the Montgomery‑Asberg depression rating scale over the course of treatment for depression. Int J Methods Psychiatr Res. 2013;22(3):175‑184. doi:10.1002/mpr.1388 10. Thase ME, Harrington A, Calabrese J, Montgomery S, Niu X, Patel MD. Evaluation of MADRS severity thresholds in patients with bipolar depression. J Affect Disord. 2021;286:58‑63. doi:10.1016/j.jad.2021.02.043

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